GDP Non-Compliance Report: Failure to Meet the GDP Principles of Cold Chain Products
Register now for ECA's GMP Newsletter
The competent authority of Portugal (National Authority of Medicines and Health Products, I.P.) has entered a new GPD Non-Compliance Report dated 24 May 2022 into the EudraGMDP database.
On 17 May 2022, the authority inspected a company located in Azambuja, Portugal . During that inspection, it came to light that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.
In the report, the authority lists the following four deficiencies: "The wholesaler does not comply with the GDP principles of cold chain products, as the procedure in case of breakdown cold chamber wasn`t triggered." Further details on the nature of the violation are not provided by the authority.
As a consequence, the wholesale authorisation concerning cold chain products (requiring low temperature handling) was suspended.
Source: EudraGMDP Database (Inspection Date: 17 May 2022; Report Number: A015/09/H/006/2021/I02 NCR). * * To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.
Related GMP News
16.01.2025EMA adds Considerations for Wholesale Distributors and Brokers on suspicious Offers
16.01.2025Swissmed informs about Control Campaign against illegal Trading in Medicinal Products
16.01.2025Two new PICS Documents on Remote Assessments published
16.01.2025The GDP Non-Compliance Reports of 2024 - An Overview
17.12.2024GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT
17.12.2024Romanian Authority Issues further GDP Non-Compliance Report